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MM120

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |Definium Therapeutics, Inc.|Last Updated: Mar 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment149
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06941844A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge)PHASE3 ACTIVE NOT_RECRUITING 149Apr 14, 2025May 1, 2027Mar 13, 202625 United States
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Study Endpoints
Primary Endpoints
Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6
Baseline to Week 6

The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.

Secondary Endpoints
Change from Baseline in the MADRS total score at Week 12, Week 4, Week 2, and Week 1
Week 12, Week 4, Week 2, and Week 1
MADRS response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period
Baseline to Week 12
MADRS remission (total score ≤10) at each timepoint assessed during the 12-week double-blind treatment period
Baseline to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1 - PlaceboPLACEBO_COMPARATORA substance that is designed to have no therapeutic value
Arm 2 - 100µg MM120 (LSD D-Tartrate)EXPERIMENTALA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
Interventions
NameTypeDescription
PlaceboOTHERA substance that is designed to have no therapeutic value
MM120 (LSD D-Tartrate)DRUGA psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)
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Eligibility Criteria
Age Range18 Years — 74 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: 1. Diagnosis of MDD per DSM-5 2. Male or female aged 18 to 74 3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration 4. MADRS Total Score ≥26 5. CGI-S Score ≥4 Exclusion Criteria: 1. Certain psychiatric disorders (other than major depres...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06941844primaryCompletionDate: changed
LOWMay 24, 2026NCT06941844studyFirstPostDate: changed